# K182604: New Era

- Pathway: 510(k) (Traditional)
- Applicant: Step UP Skin Laser, LLC
- Decided: Nov 14, 2018 after 54 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K910422 (1992). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161692: Diode Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2016) Summary page 6.

## Recalls of this device
- Jan 29, 2020 · Class II · Z-0440-2021: The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

## Indications for use
The New Era Laser is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K182604
Methodology: https://510kreport.com/methodology